Archive: Company News
Company News: InDex Pharmaceuticals regains European rights to Kappaproct® in ulcerative colitis
InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.
The termination of the agreement follows Almirall’s recent repositioning of their R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that their new strategy is to become a leading specialty pharmaceutical company with a strong focus on improving the lives of Dermatology patients and that the company will use its strong cash position to fund growth opportunities in this direction.
Kappaproct® is InDex Pharmaceutical’s lead drug candidate and is in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). The recent COLLECT study was conducted in seven European countries and included 131 patients with moderate to severe ulcerative colitis with inadequate response to conventional therapy. They received either Kappaproct® or placebo in addition to conventional treatment. Kappaproct® demonstrated statistically significant effects on endpoints that are highly relevant both from a regulatory and clinical perspective such as key clinical symptoms, i.e. blood in stool and number of stools, and mucosal healing. The primary endpoint of clinical remission at 12 weeks using the CAI score was not met due to an unexpectedly high placebo rate for this endpoint. The next clinical study with Kappaproct® is currently being planned in discussion with EU and US regulatory agencies.
Company News: Curetis’ Unyvero System Selected for Global Phase III Antibiotics Trial
– Unyvero to be used for pathogen identification and patient inclusion at several clinical sites across Europe
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Curetis’ Unyvero System will be used in a Phase III trial of a novel formulation of the antibiotic Amikacin. Unyvero was chosen as a platform to detect pathogens and antibiotic resistances in patients to be enrolled at intensive care units at several clinical trial sites across multiple European countries. Unyvero will be used to support patient identification and help boost enrollment rates at these sites.
Amikacin is an aminoglycoside antibiotic marketed for the treatment of severe, hospital-acquired infections with multidrug-resistant Gram-negative bacteria. The trial is evaluating the efficacy of a novel drug-device combination as an adjunctive therapy for Gram-negative pneumonia in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The trial is recruiting approximately 650 patients at trial sites worldwide.
Under the terms of the agreement with the sponsor of the trial, Curetis will deliver Unyvero systems and CE-IVD marked P55 cartridges to the trial sites as well as install the systems and provide training and technical support at these sites. The sponsor will fully reimburse Curetis for systems, training, services and consumables. Further financial details were not disclosed.
Company News: ISA Pharmaceuticals Further Strengthens IP Position on Lead Compound ISA101
– Three additional European patents and market exclusivity granted for the use of key active ingredients of ISA101
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced it has strengthened the IP position of its lead compound ISA101. The European Patent Office has granted three patents (EP2267132, EP2112157, EP2468763) which relate to the use of HPV antigen-based peptides. ISA101, a novel immunotherapeutic consisting of synthetic long peptides (SLP®s), targets severe diseases triggered by human papillomavirus (HPV) infection.
The patents cover the application of a variety of long peptides derived from the E6 and E7 proteins of HPV, including novel epitopes or peptides with specified features, and provide exclusivity for the treatment of persistent HPV infections and resulting diseases.
ISA101 is based on ISA Pharmaceuticals´ proprietary SLP® platform and is currently in clinical Phase I/II trials in cervical cancer and anal intraepithelial neoplasia (AIN).
Company News: Lead Pharma Appoints Three Seasoned Industry Experts to its Supervisory Board
– Jan Egberts, M.D., Ir. Jan van der Hoeven and Daan van den Noort, M.D. join newly established Supervisory Board
Lead Pharma, a pharmaceutical company developing innovative medicines for the treatment of autoimmune diseases and cancer, today announced that it has appointed Dr. Jan Egberts, Ir. Jan van der Hoeven and Daan van den Noort to its newly established Supervisory Board.
Jan Egberts, M.D., has over 25 years of executive experience in the pharmaceutical and medical device sectors, most recently as Chief Executive Officer of Agendia Inc., a molecular diagnostics company. Prior to this, Dr. Egberts was Chief Executive Officer of OctoPlus N.V., a specialty pharmaceutical company, which was acquired by Dr. Reddy’s Laboratories Ltd. in 2013. He also served as a Senior Healthcare Advisor for 3i Group plc and as President, Chairman and Chief Executive Officer of NovaDel Pharmaceuticals Inc. In addition, he held multiple business development and general management positions at Johnson & Johnson, Merck & Co. and Mölnlycke Health Care. Dr. Egberts, who graduated from Erasmus University Medical School in the Netherlands and obtained his MBA from Stanford, also serves on the Supervisory Board of several other private and public healthcare companies.
Ir. Jan van der Hoeven brings more than 30 years of experience in the biopharmaceutical industry. In 1983, he was co-founder of the CRO NOTOX, which he also headed until it was acquired by WIL Research Laboratories in 2006. In addition, since 1988 he has advised numerous life sciences companies, e.g. as a member of the Supervisory Board. He is also an ambassador of Wageningen University (Wageningen, The Netherlands). Before founding NOTOX, he worked as a scientist at Wageningen University for six years with emphasis on the relation of food and cancer. He (co-)authored over 30 scientific publications and has been awarded the EEMS Young Scientist Award in 1985. In 2003, he received the price for entrepreneurship from Wageningen University. Ir. van der Hoeven graduated from Wageningen University.
Daan van den Noort, M.D., brings over 25 years of experience as a manager and venture capitalist in the pharmaceutical and biotechnology industry in Europe. Among others, he served as General Manager for Genentech, Asta Medica, and Ferring in The Netherlands. From 2001 to 2011, he acted as the Chief investment Officer of the Biotech Turnaround Fund. He serves on several international boards of investment companies active in the biopharmaceutical industry. Mr. van den Noort holds an MD degree from the Free University of Amsterdam.